USFDA conducts pre-approval inspection at Lupin’s Pune Biotech facility

20 Sep 2025 Evaluate

U.S. Food and Drug Administration (USFDA) has conducted a product-specific Pre-Approval Inspection at Lupin’s Pune Biotech facility. The inspection has been conducted from September 08 to September 19, 2025. The inspection closed with four observations.

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

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